Myelodysplastic Syndromes News and Research

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Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

Cyclacel to present results of sapacitabine Phase 2 trial for MDS at ASH Meeting

Cyclacel Pharmaceuticals, Inc. announced today that updated Phase 2 clinical trial results of sapacitabine for the treatment of myelodysplastic syndromes (MDS) will be presented at a poster presentation during the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, on Saturday, December 4, 2010.

19 Nov 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

13 Sep 2010

NewYork-Presbyterian /Columbia sets up new Myelodysplastic Syndromes Center

NewYork-Presbyterian Hospital/Columbia University Medical Center has established a new center devoted to research and treatment of pre-leukemia blood disorders. Known as the Myelodysplastic Syndromes Center, it is one of the largest programs of its kind in the nation.

31 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Cyclacel second-quarter net loss decreases to $6.5 million

7 Aug 2010

Role of enzyme GSTP1-1 in progression of cancer, other diseases associated with increased cell proliferation

Telik, Inc. today announced the publication of a review in the journal, Cell Death and Differentiation: Glutathione transferases as mediators of signaling pathways involved in cell proliferation and cell death; http://www.nature.com/cdd/journal/vaop/ncurrent/full/cdd201080a.html. This review describes recent advances in the understanding of the important role that the enzyme GSTP1-1 plays in the progression of cancer and other diseases associated with increased cell proliferation.

13 Jul 2010

FDA grants Cyclacel's sapacitabine orphan drug designation for AML and MDS

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's sapacitabine (CYC682) product candidate for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

1 Jul 2010

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

Cyclacel reports positive interim data from sapacitabine Phase 2 study for myelodysplastic syndromes

Cyclacel Pharmaceuticals, Inc. announced today interim response data from a Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes (MDS) that have failed hypomethylating agents. The data were presented at an oral poster discussion session at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

8 Jun 2010

Interim data from Phase 2 clinical trial of sapacitabine in patients with MDS to be presented at ASCO 2010

Cyclacel Pharmaceuticals, Inc. announced that new interim data from an ongoing, multicenter, Phase 2 clinical trial of oral sapacitabine, the Company's lead product candidate, will be presented at an oral poster discussion during the 2010 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois on Monday, June 7, 2010.

21 May 2010

Cyclacel Pharmaceuticals reports net loss of $5.1M for first-quarter 2010

14 May 2010

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

29 Apr 2010

High incidence of MDS among seniors, elderly at increased risk of premature death: Study

Myelodysplastic syndromes - a group of serious blood cancers - are nearly five times more common in seniors than previously thought, according to a new study by researchers from the John Theurer Cancer Center at Hackensack University Medical Center.

27 Apr 2010

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

12 Mar 2010

NICE rejects azacitidine for treatment of MDS in patients ineligible for stem cell transplants

A drug for treating a group of conditions that affect the bone marrow is unlikely to be made available on the NHS in England and Wales after the body which provides independent advice on treatments said that it is unlikely to be cost-effective.

8 Mar 2010

VIDAZA prolongs survival in AML patients

The Myelodysplastic Syndromes (MDS) Foundation says a study published this week in the Journal of Clinical Oncology concludes VIDAZA (azacitidine) “prolongs survival and is well tolerated” in patients with acute myeloid leukemia (AML) - an aggressive form of leukemia that in many cases progresses from MDS.

3 Feb 2010

Promising results in mice could prevent fatal iron buildup in humans

A new study shows that a protein found in blood alleviates anemia, a condition in which the body's tissues don't get enough oxygen from the blood. In this animal study, injections of the protein, known as transferrin, also protected against potentially fatal iron overload in mice with thalassemia, a type of inherited anemia that affects millions of people worldwide.

27 Jan 2010